Clinical Trial Period Main
Item
for main period (nn5401-3590):
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of type 2 diabetes mellitus for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Absent
Item
insulin naïve subjects
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Metformin | Antidiabetics Oral Quantity
Item
treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
boolean
C0025598 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) between 7.5 - 11.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) no higher than 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Extension Period
Item
for extension period (nn5401-3726):
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Informed Consent
Item
informed consent obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1])
Treatment completed Clinical Trial Specified
Item
must have completed the 26-week treatment period (visit 28) in trial nn5401-3590
boolean
C0580352 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Clinical Trial Period Main
Item
for main period (nn5401-3590):
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
GLP-1 Receptor Agonist | Thiazolidinediones
Item
treatment with glucagon like peptide-1 (glp-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
boolean
C2917359 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Cardiovascular Disease
Item
cardiovascular disease diagnosed within 6 months before trial start
boolean
C0007222 (UMLS CUI [1])
Extension Period
Item
for extension period (nn5401-3726):
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Change of medication Anticipated | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (mao) inhibitors
boolean
C0580105 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
Lifestyle changes Anticipated | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Eating habits Variation
Item
anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
boolean
C0870811 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C1658633 (UMLS CUI [2])
C0555008 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
C4316563 (UMLS CUI [4,1])
C0205355 (UMLS CUI [4,2])
C1266864 (UMLS CUI [5,1])
C0205419 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])